Suture packaging

ABSTRACT

A package for objects such as sutures which are to be contained under conditions of complete sterilization is disclosed along with a method for in-line sterilization packaging of the objects on mass production basis. The package includes an inner packet in which is received a sterile surgical object such as a coil of suture material, the inner packet being substantially hermetically sealed and at least initially having a sterilizing gas confined therein. The sealed inner packet in turn is received in an outer packet of the same general construction as the inner packet and which also is substantially hermetically sealed and initially has a sterilizing gas confined therein. Both the inner and outer packets can be opened readily by peelably removing the respective packet closure lids from associated packet blisters which form the bottoms of the packets. The package is made by filling the inner packet blister with a sterile surgical object, then tacking a lid onto the blister and confining the inner packet in a vacuum chamber to remove air from the inner packet. A positive pressure of a sterilizing gas is then admitted to the chamber so as to initiate killing any bacteria on the surgical object and render it and the interior of the inner packet sterile. The lid is then completely sealed to its associated blister while still in the chamber so that a quantity of the sterilizing gas is captured within the sealed inner packet. The sealed inner packet is then removed from the vacuum chamber and placed in the outer packet blister and a closure lid is tacked in place on the blister. The outer packet and its contents is then placed in a chamber and subjected to a vacuum to remove air from the outer packet after which, a positive pressure of sterilizing gas is admitted to chamber to render the interior of the outer packet and exterior of the inner packet sterile. The lid of the outer packet is then completely sealed to its associated blister while still in the chamber and under pressure of the sterilizing gas thereby to capture within the sealed outer packet a quantity of such gas.

United States Patent 91 Kemble 111 3,726,057 [4 Apr. 10, 1973 1 SUTUREPACKAGING Mern Kemble, [)cerficld, Ohio [73] Assignee: Cenco MedicanIndustries, Inc.,

Chicago, Ill.

[22'] Filed: Apr. 1, 1972 [21] Appl. No.: 130,485

[75] Inventor:

Related US. Application Data [62] Division of Ser. No. 851,166, Aug. 19,1969, Pat. No.

Primary Examiner-Travis S. McGehee Att0rney- Robert E. Wagner & RobertE. Browne [5 7 ABSTRACT A package for objects such as sutures which areto be contained under conditions of complete sterilization is disclosedalong with a method for in-line sterilization packaging of the objectson mass production basis.

Riall ..206/63 .3

The package includes an inner packet in which is received a sterilesurgical object such as a coil of suture material, the inner packetbeing substantially hermetically sealed and at least initially having asterilizing gas confined therein. The sealed inner packet in turn isreceived in an outer packet of the same general construction as theinner packet and which also is substantially hermetically sealed andinitially has a sterilizing gas confined therein. Both the inner andouter packets can be opened readily by peelably removing the respectivepacket closure lids from associated packet blisters which form thebottoms of the packets. The package is made by filling the inner packetblister with a sterile surgical object, then tacking a lid onto theblister and confining the inner packet in a vacuum chamber to remove airfrom the inner packet. A positive pressure of a sterilizing gas is thenadmitted to the chamber so as to initiate killing any bacteria on thesurgical object and render it and the interior of the inner packetsterile. The lid is then completely sealed to its associated blisterwhile still in the chamber so that a quantity of the sterilizing gas iscaptured within the sealed inner packet. The sealed inner packet is thenremoved from the vacuum chamber and placed in the outer packet blisterand a closure lid is tacked in place on the blister. The outer ,packetand its contents is then placed in a chamber and subjected to a vacuumto remove air from the outer packet after which, a positive pressure ofsterilizing gas is admitted to chamber to render the interior of theouter packet and exterior of the inner packet sterile. The lid of theouter packet is then complete] sealed to its associated blister whilestill in the cham er and under pressure of the sterilizing gas therebyto capture within the sealed outer packet a quantity of such gas.

5 Claims, 5 Drawing Figures PAIENIED APR 1 OiSiS Fill inner packetblistersv Position and tack seal Has an inner pocket. blisters Introduceinner packets into vacuum chamber and subject to vacuum of l-29" Hg.

Subject inner packets to positive pressure of sterilizing gas of up toIPSIG. and then completely seal lids to blisters while maintainingsterilizing gas pressure.

sum 2 or 2 sterilizing gas pressure.

introduce filled outer packets into vacuum chamber and subject to vacuumof l-29"Hg.

Position and tack seal lids an outer packet blisters.

FIG. 5

Fill outer packet blisters with sealed inner packets.

SUTURE PACKAGING This is a division of application Ser. No. 851,166filed Aug. 19,1969 now US. Pat. No. 3,613,879.

BACKGROUND OF THE INVENTION It is known to package sterile surgicalobjects, as for example, suture material in sterilized packages whichinclude an outer sealed package component enclosing a sterile, fullysealed inner package component, the latter in turn containing thesurgical object. It is also know to confine in the inner component of apluralcomponent package along with a surgical object, a sterilizingmedium or agent such as a tubing solution to effect completesterilization of the surgical object within the package over a period oftime, the tubing solution in some instances remaining in the sealedinner package component until the package is opened preliminary to usingthe surgical object. Such packages however generally embody features ofpackage construction which make it difficult to confine a sterilizinggas within both the inner and outer package components so that such gascan provide for at least some initial post packaging period, a totalpackage steriliza tion during post-packaging storage nor do suchpackages or manufacturing techniques as are known allow for modernin-|ine sterilization packaging of surgical objects in bulk orcontinuous mass production basis.

The present invention on the other hand overcomes the above-mentionedshortcomings of prior art surgical object packaging and is characterizedby its suitability for high speed, reliable in-line sterilizationpackaging.

In addition to providing a new and improved method of packaging surgicalobjects, the present invention provides an improved package forsterilized surgical objects.

SUMMARY OF THE INVENTION In accordance with the present invention animproved package for sterile surgical objects is provided which includesa completely sealed inner packet in which the surgical object isreceived and an outer packet in which the sealed inner packet isreceived. The surgical object can be any of a variety of such objectswhich are required to be rendered and maintained sterile until the timeof use by the surgeon, one such object, for example, being suturematerial. The inner packet providing enclosure structure for thesurgical object includes a box-like bottom or blister having depth,width and length dimensions sufficient to accommodate the surgicalobject and also having a continuous encircling flange extendingoutwardly of the blister body to serve as a surface to which a peelablyremovable lid can be heat sealed to provide a substantially hermeticseal of the inner packet. The inner packet lid preferably comprises aflexible sheet of metallic foil coated on one broad face with a layer ofa plastic material adapted to provide means for effecting heat sealingof the lid to the blister. The inner packet lid can be of somewhatgreater length than its associated blister to allow for folding of suchexcess length over and under a projecting end flange portion of theblister, preferably along one transverse edge of the blister and beingprovided as a tab means for the purpose of readily grasping the innerpacket to remove it from the outer packet and also to readily initiatepeeling away of the lid to expose the surgical object. The outer packetpreferably is of substantially identical construction with the innerpacket but is of sufficiently larger dimensions to house or receive theinner packet. The outer packet comprises a box-like bottom or blisterprovided with a continuous encircling flange and adapted to receivetherein in inverted position, a sealed inner packet. The outer packetalso is provided with a lid secured in substantially hermeticallyheat-sealed condition to the flanges of the outer packet blister. Boththe inner and outer packets at least initially have a sterilizing gasconfined therein which functions during at least some of the period ofpost packaging storage and handling of the package to insure the sterilecondition of the surgical object. To open the package, the outer packetlid is peeled off its associated blister to expose the sterile innerpacket. The inner packet then can be grasped by the tab means of its lidand removed from outer packet blister whereupon the inner packet lid canbe peeled off its associated blister to expose the surgical object foruse by the surgeon.

According to the present invention, in-line mass production packaging ofsurgical objects can be carried out. For this purpose a continuous stockof upright laid inner packet blisters are advanced to a station at whichthey are each filled with a surgical object, after which lids arepositioned on the flanges of the blisters and are tack-sealed to suchflanges at a number of points only so that fluid access to the innerpacket is possible. The filled inner packets are then advanced insuccession into a vacuum chamber and subjected to a condition of vacuumso as to withdraw air from the interior of the chamber and inner packet.The vacuum is then broken by admitting sterilizing gas under positivepressure only slightly above atmospheric pressure, the sterilizing gasserving to initiate killing any bacterial agency in or on the surgicalobject or the interior of the inner packet. The inner packet lid is thencompletely heat sealed to its associated blister flanges while still inthe chamber and while subjected to the presence of the sterilizing gasand with the consequence that a quantity of the sterilizing gas becomescaptured within the inner packet. The completely sealed inner packetsare then removed from the chamber and advanced to another stationwhereat they are inserted in inverted position in outer packet blisters.The outer packet lids are then tack-sealed to the associated blistersafter which the packages are advanced in succession into a vacuumchamber and exposed to a condition of vacuum. Sterilizing gas is thenadmitted to the chamber to initiate killing bacterial agency on theexterior of the inner packet and interior of the outer packet followingwhich the outer packet lids are completely sealed to their blisters inthe same manner attending sealing of the inner packets.

The invention accordingly comprises the several steps and the relationof one or more of such steps with respect to the others as will beexemplified in the process to be described as well as the features ofconstruction, combination of elements and arrangement of partsexemplified in the construction hereinafter set forth and the scope ofthe invention will be indicated in the claims.

BRIEF DESCRIPTION OF THE DRAWINGS A fuller understanding of the natureand objects of the invention will be had from the following detaileddescription taken in conjunction with the accompanying drawings inwhich:

FIG. 1 is a perspective view of a sterilized suture package constructedin accordance with the principles of the present invention, the peelablyremovable lid of the outer packet being shown partly removed.

FIG. 2 is a plan view of the suture package shown in FIG. 1, showing thepeelably removable lid almost completely stripped off from the outerpacket blister.

FIG. 3 is a longitudinal sectional view of the sterilized suture packageshown in FIGS. 1 and 2 as taken along the line IIl-III in FIG. 2, theremovable lid of the outer packet being shown in its fully sealedposition of closure on its associated blister.

FIG. 4 is a perspective view of the inner packet in which coiled suturematerial is contained, the inner packet being shown in its sealedcondition with the pull tab of the lid with which initiation of peelingof the packet lid is effected being shown folded under a projectingflange portion of its associated blister.

FIG. 5 is a block diagram of the several steps involved in thecontinuous or bulk packaging operations with which suture packages ofthe present invention can be made.

Throughout the description, like reference numerals are used to denotelike parts in the drawing.

DESCRIPTION OF THE PREFERRED EMBODIMENTS The present invention providesan improved package for sterile surgical objects as well as a method ofin-line sterilization of such packages on mass production basis.Although sterile surgical objects will be exemplified herein by way ofexample as being suture material and the packaging of the same, it willbe understood that the present invention has broader application beinguseful for packaging objects of wide description wherein the basicconsideration is establishment and maintenance of a totally sterilizedpackage. In the following description, the construction of the improvedpackage for'sterile surgical objects will be discussed first.

As can be noted from the accompanying drawings and with particularreference to FIGS. 1 and 3, the package it will be noted is comprised oftwo major components, a substantially hermetically sealed inner packet12 in which is received the surgical object 14, and a substantiallyhermetically sealed outer packet 16 in which the inner packet 12 isreceived. The surgical object 14 is shown by way of example as being acoil of suture material wound on a card support and including the usualsuturing needle. The inner packet 12 and outer packet 16 preferably aresubstantially identical in construction differing essentially only as tosize. The outer packet 16 includes a box-like bottom section or blister18 which is a shaped, relatively rigidized structure and preferably madefrom a transparent plastic material and which is provided withoutstanding, encircling flanges 20, the latter being of comparativelygreater dimension along one transverse edge as at 22 for a purpose whichshall appear. The outer packet 16 also includes a closure member or lid24 which is generally coextensive with the plan expanse of itsassociated blister and which is comprised of a layer of metallic foil 26coated at its underface with a layer of a thermoplastic material 28, oflatter being provided to enable effecting a heat seal of the lid 24 tothe flanges of the blister 18, the heat seal being along a continuousencircling course, the pattern of which may be best seen as denoted bythe seal line 30 in FIGS. 1 and 2 and the seal connections 30 in FIG. 3.The quality of the heat seal is such as to provide a substantiallyhermetic seal closure of the outer packet. As used herein, asubstantially hermetic seal is intended to mean a condition of sealwhich substantially retards for a period of time, e.g., one week to tendays, the rote of dissipation of sterilizing gas under pressure from thesealed packets. As can be noted from FIGS. l-3 and end portion of thelid 24 is not sealed to the blister flange along edge area 22 so thatconvenient digital access is available for peelably removing the lidfrom the blister when opening the package.

As was indicated earlier, the outer packet 16 receives and contains thesurgical object 14. The inner packet 12 as can be noted from FIGS. 3 and4 and like outer packet 16, includes a box-like bottom or blister 32 anda flexible closure lid 34, the blister 32 being provided with flanges inthe same manner as blister 18 to serve as surfaces to which the closurelid 34 can be heat sealed. However, closure lid 34 has a somewhatgreater length than blister 32 so that such excess length can be foldedaround and under one transverse flange of blister 32 to thereby providetab means 36 for grasping the inner packet 12 when removing it from theouter packet and also for initiating peeling off of the lid 34 fromblister 32. As can be seen in FIG. 3, the inner packet 12 preferably isreceived in inverted position in the outer packet 16 so that the lidthereof which can be marked with identifying indicia can be viewedreadily.

The package 10 when sealed is completely sterilized and during postpackaging storage and handling remains so with respect to the interiorof the outer packet and both the exterior and interior of the innerpacket. That this condition of sterilization obtains is due, inter alia,to the hermetic seal of each packet and to the presence of sterilizinggas within each packet. While the sterilizing gas is initially confinedwithin each packet at some positive pressure above atmospheric andpreferably not greater than 1 PSIG, it will dissipate from the packagesat a very slow rate due to the character of the heat seal. Moreover, thecharacter of the heat seal is such as to function as a filter to preventthe incursion of bacterial agency media and hence the package retainsits sterile quality although the sterilizing gas may have long beendissipated therefrom. The sterilizing gas can be any known gaseousmedium suited for the intended purpose. A mixture of ethylene oxide andan inert gas such as carbon dioxide or freon gas in percentages of about12 percent ethylene oxide and 88 percent inert gas is a particularlyeffective sterilizing gas.

To open package 10, the user first peels off lid 24 from outer packet 16in the manner shown in FIGS. 1 and 2. The inner packet 12 is thenremoved from blister 18 by grasping the inner packet 12 at tab means 36.The inner packet is then opened in the same manner to expose thesurgical object 14 which can be removed directly by the surgeon withouthaving been touched by any other person or object which could be a causeof contamination.

Description now will be given of the improved method by which sterilesurgical objects can be packaged in an in-line or bulk sterilizationprocess, for which purpose continuing reference is made to FIG. 5. Thepresent invention as has been stated earlier provides that suturepackages can be made most readily on mass production basis. Theapparatus with which such packages can be made can be of knownconstruction provided it is capable of performing the functions now tobe described. A continuous supply of individual surgical objects are, atan appropriate loading station, laid in inner packet blisters. The innerpacket blisters if the operation is to be a bulk sterilization can beformed as a plurality of such blisters, tag, in a sheet. The filledupright arranged inner packet blisters then have their associatedclosure lids positioned thereon as they advance along the productionline and the lids are tacksealed to the blisters. The inner packetsarethen advanced in successive order or bulk quantity into a suitableconditioning chamber and a vacuum is drawn in the chamber to subject theinner packets to a condition of vacuum as so to withdraw air from boththe chamber and the interior of the inner packets. The degree of vacuumcan vary from about 1 to about 29 in. Hg., a particularly preferredoperating range being 5-29 in. Hg. As soon as the vacuum in the chamberhas pulled down to the desired level, it is broken by admitting a flowof sterilizing gas under positive pressure into the chamber. Thesterilizing gas can be any one of a number of such sterilizing agents asare known, a particularly suitable gas for this purpose being a mixtureof ethylene oxide and an inert gas such as carbon dioxide or freon inproportions of about 12 percent of the former and 88 percent of theletter with the gas pressure being varied depending upon therequirements of the packaging. However, for the package shown in FIGS.1-4, a pressure of about I PSlG. is particularly suitable. As soon asthe sterilizing gas invests the inner packets it immediately initiateskilling of any bacterial agency in or on the inner packets and thesurgical objects. As soon as the requisite pressure of sterilizing gasis reached within the chamber, the inner packets are then completelysealed by heat-sealing the closure lids to the flanges of the associatedblisters, such heat sealing being effected within the chamber with thegas pressure being maintained until sealing is completed.

The sealed inner packets are then removed in succession from the chamberand advanced to a station at which they are placed in inverted positionin outer packet blisters and whereupon lids are tack-sealed to the outerpacket blisters, the respective sealed inner packets of course will atthis point if they are made in bulk be separated from the base sheet.Similarly if the operation is a bulk one, the individual sealed innerpackets may be received in the outer packet blisters while the latterare still joined in bulk from a single formed-sheet. The filled but yetunsealed outer packets are then advanced into a chamber and subjected tothe vacuum treating gas exposure and lid sealing in the same manner asapplicable to the inner packets. The thus finished package is completelysterilized on the inside of the outer packet and both the inside andoutside of the inner packet. Moreover, both the inner and outer packetsare filled with sterilizing gas which is retained for an initial periodin the respective packets during post packaging periods and dissipatedonly slowly therefrom due to the heat seal connection of the closurelids to the blisters which is effective to substantially retard the roteof gas inflow or outflow from the packets.

It will be thus seen that the objects set forth above, among those madeapparent from the preceding description, are efficiently attained, andsince certain changes can be made in the above construction anddifferent embodiments of the invention could be made without departingfrom the scope thereof, it is intended that all mater contained in theabove description or shown in the accompanying drawing shall beinterpreted as illustrative and not in a limiting sense.

What is claimed is:

1. A method for in-line sterile packaging of surgical objects in innerand outer component packages which comprises receiving successive onesof said surgical objects in a box-like blister and tack-sealing closureson each blister to thereby provide the inner component of each package,

introducing said inner components into a conditioning zone andsubjecting them to a condition of vacuum, thereafter introducing asterilizing gas into said conditioning zone at a positive pressure toinitiate destruction of any bacterial agency present in the surgicalobjects and said inner components,

thereafter hermetically heat-sealing the inner component closures totheir respective blisters while in said conditioning zone,

removing said sealed inner components from said conditioning zone andreceiving them each in separate box-like blisters and tack-sealingclosures on the last-mentioned blisters to thereby provide package outercomponents,

then introducing said outer components into a conditioning zone andsubjecting them to a condition of vacuum,

thereafter introducing a sterilizing gas into said conditioning zone ata positive pressure to initiate destruction of any bacterial agencypresent in said outer components and on the exterior of said innercomponents, and

thereafter hermetically heat-sealing the outer component closures totheir respective blisters while in said conditioning zone.

2. The method of claim 1 wherein said sterilizing gas is a mixture ofethylene oxide and :an inert gas.

3. The method of claim 2 wherein said ethylene oxide and inert gas arepresent in said mixture in percentages of substantially 12 percent and88 percent respectively.

4. The method of claim 1 wherein the condition of vacuum to which saidinner and outer components are subjected is in the range between about 1in. Hg. and 29 in. Hg.

5. The method of claim 1 wherein the positive pressure at which saidsterilizing gas is introduced into said conditioning chamber is up toabout 1 PSlG.

1. A method for in-line sterile packaging of surgical objects in innerand outer component packages which comprises receiving successive onesof said surgical objects in a box-like blister and tack-sealing closureson each blister to thereby provide the inner component of each package,introducing said inner components into a conditioning zone andsubjecting them to a condition of vacuum, thereafter introducing asterilizing gas into said conditioning zone at a positive pressure toinitiate destruction of any bacterial agency present in the surgicalobjects and said inner components, thereafter hermetically heat-sealingthe inner component closures to their respective blisters while in saidconditioning zone, removing said sealed inner components from saidconditioning zone and receiving them each in separate box-like blistersand tack-sealing closures on the last-mentioned blisters to therebyprovide package outer components, then introducing said outer componentsinto a conditioning zone and subjecting them to a condition of vacuum,thereafter introducing a sterilizing gas into said conditioning zone ata positive pressure to initiate destruction of any bacterial agencypresent in said outer components and on the exterior of said innercomponents, and thereafter hermetically heat-sealing the outer componentclosures to their respective blisters while in said conditioning zone.2. The method of claim 1 wherein said sterilizing gas is a mixture ofethylene oxide and an inert gas.
 3. The method of claim 2 wherein saidethylene oxide and inert gas are present in said mixture in percentagesof substantially 12 percent and 88 percent respectively.
 4. The methodof claim 1 wherein the condition of vacuum to which said inner and outercomponents are subjected is in the range between about 1 in. Hg. and 29in. Hg.
 5. The method of claim 1 wherein the positive pressure at whichsaid sterilizing gas is introduced into said conditioning chamber is upto about 1 PSIG.